Reduce tremor stiffness and slowness
- Trial ID
- NCT06169852
- Official Title
- Stimulus-Evoked Directional Field Potentials to Guide Subthalamic and Pallidal DBS for PD
- Goal
- Reduce tremor stiffness and slowness
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University of Alabama at Birmingham
- Study Type
- INTERVENTIONAL
- Enrollment
- 36 participants
- Conditions
- Parkinson Disease
- Interventions
- Unilateral dual-target (STN/GPi) DBS
Summary For Families
The goal is to better control disabling motor problems like wearing off, dyskinesias, and on/off fluctuations by improving how deep brain stimulation reaches two key targets, the subthalamic nucleus and the globus pallidus interna. During awake, unilateral surgery surgeons record stimulus-evoked directional field potentials, intraoperative electrical signals that help steer directional DBS leads so stimulation more precisely modulates motor circuits; DBS then delivers continuous high-frequency pulses to STN and/or GPi to reduce tremor, rigidity, and slowness and to smooth out levodopa-related fluctuations and dyskinesia. Adults 18 to 89 with advanced, levodopa-responsive idiopathic Parkinson's disease for at least 4 years who still have disabling motor fluctuations or dyskinesias despite medical therapy, and who meet basic cognitive and mood criteria and can tolerate awake surgery, are being enrolled.
Locations
- University of Alabama at Birmingham, Birmingham, Alabama, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Unilateral dual-target (STN/GPi) DBS. The goal is to better control disabling motor problems like wearing off, dyskinesias, and on/off fluctuations by improving how deep brain stimulation reaches two key targets, the subthalamic nucleus and the globus pallidus interna. During awake, unilateral surgery surgeons record stimulus-evoked directional field potentials, intraoperative electrical signals that help steer directional DBS leads so stimulation more precisely modulates motor circuits; DBS then delivers continuous high-frequency pulses to STN and/or GPi to reduce tremor, rigidity, and slowness and to smooth out levodopa-related fluctuations and dyskinesia. Adults 18 to 89 with advanced, levodopa-responsive idiopathic Parkinson's disease for at least 4 years who still have disabling motor fluctuations or dyskinesias despite medical therapy, and who meet basic cognitive and mood criteria and can tolerate awake surgery, are being enrolled.
- Who can participate?
- Participants must be between 18 Years and 89 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 4 years and 11 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.